WO2012093772A2 - Implant pour insertion in vivo, formé d'une couche de revêtement poreux située sur ledit implant - Google Patents

Implant pour insertion in vivo, formé d'une couche de revêtement poreux située sur ledit implant Download PDF

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Publication number
WO2012093772A2
WO2012093772A2 PCT/KR2011/008508 KR2011008508W WO2012093772A2 WO 2012093772 A2 WO2012093772 A2 WO 2012093772A2 KR 2011008508 W KR2011008508 W KR 2011008508W WO 2012093772 A2 WO2012093772 A2 WO 2012093772A2
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WO
WIPO (PCT)
Prior art keywords
coating layer
implant
pores
porous coating
test
Prior art date
Application number
PCT/KR2011/008508
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English (en)
Korean (ko)
Other versions
WO2012093772A3 (fr
Inventor
선두훈
김용식
김정성
신태진
병수 김
Original Assignee
주식회사 코렌텍
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by 주식회사 코렌텍 filed Critical 주식회사 코렌텍
Priority to US13/997,537 priority Critical patent/US20130282135A1/en
Priority to CN201180064038.XA priority patent/CN103328016B/zh
Priority to EP11855061.5A priority patent/EP2671598A4/fr
Publication of WO2012093772A2 publication Critical patent/WO2012093772A2/fr
Publication of WO2012093772A3 publication Critical patent/WO2012093772A3/fr
Priority to US14/831,159 priority patent/US9895229B2/en

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Classifications

    • D—TEXTILES; PAPER
    • D07—ROPES; CABLES OTHER THAN ELECTRIC
    • D07B—ROPES OR CABLES IN GENERAL
    • D07B1/00—Constructional features of ropes or cables
    • D07B1/14—Ropes or cables with incorporated auxiliary elements, e.g. for marking, extending throughout the length of the rope or cable
    • D07B1/148—Ropes or cables with incorporated auxiliary elements, e.g. for marking, extending throughout the length of the rope or cable comprising marks or luminous elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • D—TEXTILES; PAPER
    • D07—ROPES; CABLES OTHER THAN ELECTRIC
    • D07B—ROPES OR CABLES IN GENERAL
    • D07B1/00—Constructional features of ropes or cables
    • D07B1/06—Ropes or cables built-up from metal wires, e.g. of section wires around a hemp core
    • D07B1/0693—Ropes or cables built-up from metal wires, e.g. of section wires around a hemp core having a strand configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing

Definitions

  • the present invention relates to an implant that is inserted into a living body such as an artificial knee joint, an artificial hip joint, and more specifically, to increase the porosity of the porous coating layer formed on the surface of the implant while promoting bone adhesion into the pores while also in the implant and coating layer and coating layer
  • the adhesion between the particles can be increased, and the shape of the voids in the porous coating layer has a radius
  • the present invention relates to a implant for bioinsertion in which a porscoscoing layer is formed, which is connected to each other to increase bonding force with bone.
  • Bio-insertion implant is a general term that is inserted into the human body through a surgical operation, for example, femoral joint member, tibial joint member, or artificial hip joint procedure, which are often inserted into the femur and tibial regions for artificial knee joint surgery. Implants such as acetabular cups and femoral stems, which are inserted into the hip and femur areas.
  • Implants such as (1) and acetabular cups (3) are made of, for example, titanium alloys that are harmless to the human body.
  • the femoral head (5) formed of ceramic or metal material is fixed, and in the acetabular cup (3), the femoral head (5) is accommodated and the Daeung hemisphere (6) can be inserted.
  • the Daeung hemispheres 6 are made of ceramic material or polymer polyethylene.
  • the artificial hip joint configured as described above is configured to allow the femoral head 5 to rotate about the Daeung hemisphere 6 according to the movement of the femur 2 and the femoral stem 1.
  • the femur coupling member 7 is fixed to the tibia side end of the femur 8 and the tibia coupling to the femur side end of the tibia 10.
  • the member 9 is fixed so that the femoral coupling member 7 can rotate in relation to the tibial coupling member 9.
  • the material of the implant is mainly titanium, titanium alloys, or cobalt chromium alloys.
  • titanium and titanium alloys are not only easy to process but also have excellent biocompatibility, mechanical strength and corrosion resistance, and thus are widely used as biomaterials.
  • implants made of only titanium, titanium alloys or chromium cobalt alloys have a problem of increasing the probability of failure during the procedure because the initial bonding time with the bone is long during implantation.
  • Adhesion strength of the coating layer of course weakens the adhesion between the particles in the coating layer, the coating layer formed on the surface during the implant procedure is easily released due to friction, so that the released coating layer lowers the growth in bone, resulting in a decrease in the stress dispersion effect In the end, the implant is firmly anchored to the bone This can cause problems.
  • the present invention has been made to solve the above problems,
  • An object of the present invention is to increase the porosity of the porous coating layer formed on the surface of the implant for implantation of the implant to increase the adhesion between the implant and the coating layer and the particles in the coating layer while improving the adhesion of the pores into the pores are formed It is to provide an implant for implantation.
  • Another object of the present invention is to form a shape of the pores in the porous coating layer bent up and down the radius of 100 ⁇ 300, to increase the bonding force with the bone growing in the pores It is to provide a implant for a bio-insertion layer is formed, characterized in that to promote osteoadhesion.
  • Still another object of the present invention is to provide an implant for bioinsertion in which a pores coating layer is formed in which the pores and the pores growing in the pores are connected to each other to increase the bonding force between the pores and pores in the pores coating layer. It is.
  • the implant for bioinsertion in which the porscoting layer is formed to achieve the above object of the present invention includes the following configuration.
  • Bio-insertable implant having a porous coating layer formed in accordance with an embodiment of the present invention is a porous coating layer is formed on the outer surface of the implant, the porous coating layer is formed with a metal powder coating metal surface on the implant metal surface using a rapid metal forming technique
  • the coating thickness is 200 ⁇ 1000
  • the pore size is 150 ⁇ 800 / ⁇
  • the pore size is formed at 40 ⁇ 70% by volume, so that the porosity of the porous coating layer is high.
  • the adhesion between the coating layer and the metal powder in the coating layer can be increased.
  • the porous coating layer in the bioinsertion implant in which the porous coating layer is formed according to the present invention, includes a shape in which the voids in the coating layer are curved up and down with a radius of 100 to 300 j ⁇ , Characterized in that it can increase the bonding force with the bone growing in.
  • the porscoting layer is formed along a tool path in which 'right-forward-left-forward' is continuously repeated,
  • the rate of interconnection of the pores and pores in the coating layer is characterized in that the bones growing in the pores are connected to each other to increase the bonding force with the bones.
  • the implant metal is titanium (Ti), titanium (Ti) alloy, cobalt chromium (CoCr) alloy and stainless steel alloy. It consists of a biocompatible material selected from the group consisting of, the metal powder is composed of a biocompatible material powder selected from the group consisting of titanium (Ti) powder, titanium (TO alloy powder and cobalt chromium (CoCr) alloy powder. It is characterized by.
  • the present invention is a combination of the present embodiment and the configuration to be described below, by the use relationship The following effects can be obtained.
  • the present invention has the effect of increasing the adhesion between the implant and the coating layer and the particles in the coating layer while increasing the porosity of the poring coating dance formed on the surface of the implant for bio-insertion to promote bone adhesion into the pores.
  • the present invention is to form a shape of the pores in the poring coating layer bent up and down the radius of 100 ⁇ 300, has the effect of increasing the bonding force with the bone growing in the pores to promote bone adhesion.
  • the present invention has the effect that by increasing the ratio of the pores and pores interconnected in the porous coating layer is connected to each other the bones growing in the pores to increase the bonding force with the bones.
  • FIG. 1 is a reference diagram illustrating an artificial hip joint and an artificial knee joint as an example of an implant.
  • FIG. 2 is a conceptual diagram of a rapid metal forming technique.
  • Figure 3 is a perspective view of the implant for implantation (artificial hip joint and artificial knee joint) formed with a porous coating layer according to an embodiment of the present invention
  • Figure 4 is an electron micrograph showing the pore size of the porous coating layer of Figure 3
  • Figure 5 is an electron micrograph showing the shape and thickness of the pore of Figure 3
  • FIG. 6 is an electron micrograph showing a connection state between the pores of FIG.
  • FIG. 7 is a reference diagram showing an example in which the air gap shape and size are adjusted using the tool path.
  • 14 is a graph showing the point where the value measured in test 3 is located on the statistical data.
  • a arm plant
  • b porous coating layer
  • c void
  • Reference Signs List 101 Specimen 102: Laser Beam 103: Melt Pool 104: Cladding Material 105: Cladding Layer
  • Femoral stem 2 Femur 3: Acetabular cup 4: Pelvis 5: Femoral head 6: Corresponding hemisphere 7: Femur joint member 8: Femur 9: Tibia joint 10: Tibia
  • FIG. 2 is a conceptual diagram of a rapid metal forming technique.
  • 3 ⁇ 4 speed is a process technology for forming the porous scoping layer according to the present invention
  • Metal rapid prototyping technology uses the geometric data of a 3D shape model stored in a computer (which means 3D CAD data, CT or MRI data, and digital data measured by a 3D scanner). It is a new concept of rapid prototyping technology that can produce tools or tools needed for the production of products in a very short time.
  • the term rapid metal forming technology used in the present invention ⁇ SLS (Selective Laser Sintering), DMLSC Direct Metal Laser Sintering (SLS), Selective Laser Melting (SLM), Electron Beam Melting (EBM), laser-aided Direct Metal Tooling (DMT) , LENS (Laser-Engineered Net Shaping), DMD (Direct Metal Deposition), DMF (Direct Metal Fab) and other technologies.
  • the rapid metal forming technique is applied to the surface of the specimen 101 as shown in FIG.
  • the laser beam 102 is irradiated locally to form the molten pool 103, and at the same time, a powder-like cladding material (for example, metal or metal alloy, etc.) 104 is supplied from the outside to provide a new cladding layer ( 105).
  • Metal rapid prototyping technology calculates two-dimensional cross-sectional information from three-dimensional CAD data, and forms and corresponds to each two-dimensional cross-sectional information. By sequentially forming a cladding layer having a thickness and / or height, a three-dimensional functional metal product or is rapidly formed.
  • FIG. 3 is a perspective view of the implant (for artificial joints and artificial knee joint) for living body implants with a porous coating layer according to an embodiment of the present invention
  • Figure 4 is an electron micrograph showing the pore size of the porous coating layer of Figure 3, FIG.
  • FIG. 5 is an electron micrograph showing the shape and thickness of the pores of FIG. 3
  • FIG. 6 is an electron micrograph showing the connection state between the pores in FIG. 3
  • FIG. 7 is a pore shape and size adjusted using a tool path. True altitude, showing one example.
  • the implant for the bio-insertion of the porous coating layer formed in accordance with an embodiment of the present invention (FIG. 3 shows an artificial hip joint femoral stem and artificial knee joint in FIG. 3) is an implant (a) A porous coating layer (b) is formed on an outer surface, and the porous coating layer (b) is formed of metal powder on the implant (a) metal surface using a rapid metal forming technique, and a tool path and a laser process in the forming process.
  • the coating thickness is 200-1000
  • the pore size of the coating layer (c) is 150-800
  • the porosity is formed at 40-70% by volume
  • the porosity of the porous coating layer (b) is high while the implant (a) and the coating layer (b) A) and the adhesive force between the metal powder in the coating layer (b) can be increased.
  • the implant (a) generally has excellent biocompatibility, mechanical strength and corrosion resistance, and has suitable properties as a biocompatible material, which is a material that has been widely used, such as titanium, titanium alloy, cobalt chromium alloy, or stainless steel.
  • porous porous coating layer (b) On the outer surface of the implant (a) to ensure the success rate of the procedure by reducing the initial bonding time with the bone during human implantation.
  • the porous coating layer (b) forms porous pores (c) using a biocompatible material powder such as titanium or titanium 3 ⁇ 4 powder or cobalt chromium powder on the surface of the implant (a) to form the human body of the implant (a). It is a configuration to increase the binding force with the bone by using the bone growth within the cavity during implantation.
  • the porous coating layer required by using the rapid metal forming technique described above ( The height and shape of b), as well as porosity to secure the bone adhesion while increasing the adhesion between the femoral stem and the adhesion between the particles in the coating layer.
  • the porous coating layer (b) has a coating thickness of 200 to 1000 / m (see FIG. 5), a size of 150 to 800 (see FIG. 4) of a pore (c) in the coating layer, and a porosity of 40 to 70% by volume ( 4) to increase the porosity of the porscoting worm (b) while increasing the bonding strength between the implant) and the coating layer (b) and the adhesion between the metal powder particles in the coating layer (b).
  • it is generally advantageous to increase the porosity in the coating layer if it is desired to improve the bonding strength with the bone through bone growth within the coating layer formed on the surface of the implant (a), that is, the bone adhesion.
  • Adhesion strength of the coating layer as well as the adhesion between the particles in the coating layer is lowered, the coating layer formed on the surface during the treatment of the beam plant (a) is easily released due to friction, so that the coating layer is released in the bone growth decreases the resulting dispersion effect Fall and eventually cause a problem that the implant (a) is not firmly fixed to the bone, in the present invention by maintaining the coating thickness and the size of the pores (c) in the gating layer (b) 40 to 70 While forming a relatively large porosity of volume%, the adhesion strength between the base material implant (a) and the adhesion between the particles in the coating layer (b) are good. This can be maintained (as evidenced by the test data described later).
  • the shape of the void (c) in the porous coating layer (b) includes a shape curved upward and downward with a radius of 100 to 300, as shown in FIG. 5, into the void (c). Allows to increase the bond with the growing bone. That is, the voids are formed in the coating layer (b) to form a void (C) to allow the bone to be resistant, while the upper and lower shapes of the void (C) are not linear, but are formed to be curved upward and downward with a radius of 100-300 /. (c) internally listed bones grow to the lower end of the curved pores (c) to eventually increase the bond between the bone and the implant (a) rather than the bone and the coating layer (b).
  • the pores (C) and the pores (c) formed in the porous coating layer (b) are interconnected so that the bones and bones growing in the pores (c) are connected to each other so that the bone adhesion force is achieved.
  • the pores c in the coating layer (b) are formed by forming the porous coating layer (b) along the tool path in which 'right-forward-left-forward' is continuously repeated as shown in Fig. 7. )
  • the gap (c) can be increased by increasing the ratio and regularity of the interconnection between the bone and the bone growing in the void (c) to increase the bone adhesion relatively.
  • FIG. 7 are electron micrographs in which the form of the formed void (c) is sequentially enlarged and displayed.
  • the test data show that the adhesion strength to the implant (a) and the adhesion between the metal powder particles in the coating layer (b) are also excellent.
  • 8 is a photograph of the specimen used in the test 1
  • Figure 9 is a photograph of the test equipment used in the test 1
  • Figure 10 is a photograph of the specimen used in the test 2
  • Figure 11 is a photograph of the test site used in the test 2
  • 12 is a photograph of the specimen used in the test 3
  • Figure 13 is a photograph of the test equipment used in the test 3
  • Figure 14 is a graph showing the point where the value measured in the test 3 is located on the statistical data
  • 15 is a photograph of the specimen used in the test 4
  • Figure 16 is a photograph of the test equipment used in the test 4
  • Figure 17 is a reference diagram showing the operating principle of the test equipment of FIG.
  • the tensile strength of the implant (a) having the porous coating layer (b) according to the present invention is an average 48.58MPa, which can confirm the excellent performance of more than 22MPa prescribed by the test criteria, the coating layer of all specimens You can see that no exits occurred.
  • Test Criteria ASTM F 1044, which is the shear force test criterion for the US FDA coating layer.
  • Test Method Shear force test equipment of the German EndoLab (Model No.
  • Specimen Size 19.05mm * Titanium base material of height 25.4 ⁇ , the coating thickness of 200 ⁇ 1000 / according to the present invention, the thickness of the pore in the coating layer 150 ⁇ 800, the pore 40 ⁇ 70 volume 3 ⁇ 4> the coating layer of FIG. dog
  • the test equipment (Model No. 302) was used to sandwich the specimen between the left and right sample holders, and then a sinusoidal dynamic load was obtained at a frequency of 20 Hz between the maximum load and the minimum load (the minimum load was set to 10% of the maximum load). Proceed with up to 10 million cycles (cycles)
  • the furnace performance can be confirmed that the fracture does not occur and the coating layer does not occur while maintaining the shear strength of 20.00 MPa even under the dynamic load applied to 10 million cycles, which is statistical data obtained by the same test as shown in the graph of FIG. 14. You can see that it is above the average value of the award.
  • Test Criteria ASTM F, the US FDA's standard for abrasion resistance testing for coatings
  • the coating layer according to the present invention also increases the binding force between the powder particles in the coating layer.
  • the implant (a) having the porous coating layer (b) according to the present invention is formed by precisely controlling the thickness of the coating layer (b) and the size and shape of the pores (c).
  • the adhesion strength between the coating layer (b) and the base material implant (a) and the adhesion between the powder particles in the coating layer (b) are also excellent.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un implant inséré chirurgicalement in vivo, tel qu'une prothèse de genou ou une prothèse de hanche, et plus spécifiquement un implant pour insertion in-vivo qui est formé d'une couche de revêtement poreux située sur ledit implant. L'indice de porosité de ladite couche de revêtement poreux formée sur la surface de l'implant est accru, de manière à permettre l'amélioration de l'ostéointégration dans les vides, tout en augmentant la force de cohésion entre l'implant et la couche de revêtement et entre les particules à l'intérieur de la couche de revêtement. En outre, on confère aux pores de ladite couche de revêtement poreux une forme verticalement incurvée avec un rayon compris entre 100 et 300 μm ; ceci permet d'accroître la force de liaison à l'os se développant dans les pores ‑ et de favoriser ainsi l'ostéointegration ‑, ainsi que d'augmenter le rapport de liaison entre un pore et un autre dans ladite couche de revêtement poreux, afin de provoquer l'interconnexion de l'os poussant dans les pores et l'accroissement de la force de liaison avec l'os.
PCT/KR2011/008508 2011-01-04 2011-11-09 Implant pour insertion in vivo, formé d'une couche de revêtement poreux située sur ledit implant WO2012093772A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US13/997,537 US20130282135A1 (en) 2011-01-04 2011-11-09 Implant for in-vivo insertion which is formed with a porous coating layer thereon
CN201180064038.XA CN103328016B (zh) 2011-01-04 2011-11-09 形成有多孔涂层的体内插入用移植物
EP11855061.5A EP2671598A4 (fr) 2011-01-04 2011-11-09 Implant pour insertion in vivo, formé d'une couche de revêtement poreux située sur ledit implant
US14/831,159 US9895229B2 (en) 2011-01-04 2015-08-20 Method for manufacturing implant having porous layer on surface thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020110000439A KR101109086B1 (ko) 2011-01-04 2011-01-04 포러스코팅층이 형성된 생체삽입용 임플란트
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US14/831,159 Continuation-In-Part US9895229B2 (en) 2011-01-04 2015-08-20 Method for manufacturing implant having porous layer on surface thereof

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US20130282135A1 (en) 2013-10-24
CN103328016A (zh) 2013-09-25
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EP2671598A2 (fr) 2013-12-11
CN103328016B (zh) 2015-06-24
WO2012093772A3 (fr) 2012-09-07

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